check_circleStudy Completed
Neoplasms
Bayer Identifier:
16821
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Safety and Effectiveness of Regorafenib
Trial purpose
This study is a prospective observational cohort study.
The study will be conducted in routine clinical practice
settings. It is planned to enroll 1000 patients with
metastatic Colorectal Cancer (mCRC) who have been
previously treated with other approved treatments for
metastatic disease and for whom a decision has been
made by the physician to treat with regorafenib
according to local health authority approved label. It is
the aim of this observational cohort study to further
characterize safety and effectiveness of regorafenib in
routine clinical practice setting.
Healthcare resource utilization in the routine provision of
care is becoming increasingly important from a health
economics and outcomes research perspective.
Therefore, another aim of this observational cohort
study is to capture healthcare resource associated with
the management of treatment emergent adverse events
in the real world setting.
The primary objective of this study is to further
characterize safety of regorafenib use in routine clinical
practice settings.
The secondary objective of this study is to assess the
effectiveness of regorafenib in routine clinical practice
settings as measured by Overall Survival (OS),
Progression Free Survival (PFS) and Disease control
rate (DCR). Health Related Quality of Life (HRQoL)
Data will be collected in applicable countries.
The study will be conducted in routine clinical practice
settings. It is planned to enroll 1000 patients with
metastatic Colorectal Cancer (mCRC) who have been
previously treated with other approved treatments for
metastatic disease and for whom a decision has been
made by the physician to treat with regorafenib
according to local health authority approved label. It is
the aim of this observational cohort study to further
characterize safety and effectiveness of regorafenib in
routine clinical practice setting.
Healthcare resource utilization in the routine provision of
care is becoming increasingly important from a health
economics and outcomes research perspective.
Therefore, another aim of this observational cohort
study is to capture healthcare resource associated with
the management of treatment emergent adverse events
in the real world setting.
The primary objective of this study is to further
characterize safety of regorafenib use in routine clinical
practice settings.
The secondary objective of this study is to assess the
effectiveness of regorafenib in routine clinical practice
settings as measured by Overall Survival (OS),
Progression Free Survival (PFS) and Disease control
rate (DCR). Health Related Quality of Life (HRQoL)
Data will be collected in applicable countries.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1034Trial Dates
April 2014 - November 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, France | |
Completed | Many Locations, Spain | |
Completed | Many Locations, Netherlands | |
Completed | Many Locations, Mexico | |
Completed | Many Locations, Austria | |
Completed | Many Locations, Taiwan | |
Withdrawn | Many Locations, Malaysia | |
Completed | Many Locations, Switzerland | |
Completed | Many Locations, Italy | |
Withdrawn | Many Locations, Canada | |
Withdrawn | Many Locations, Sweden | |
Completed | Many Locations, Denmark | |
Withdrawn | Many Locations, Norway | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Singapore | |
Completed | Many Locations, Luxembourg | |
Withdrawn | Many Locations, Belgium | |
Completed | Many Locations, Argentina | |
Withdrawn | Many Locations, Jordan | |
Withdrawn | Many Locations, Venezuela | |
Withdrawn | Many Locations, Saudi Arabia | |
Withdrawn | Many Locations, Kuwait | |
Withdrawn | Many Locations, Kazakhstan | |
Withdrawn | Many Locations, Lebanon | |
Withdrawn | Many Locations, Qatar | |
Withdrawn | Many Locations, United Arab Emirates | |
Withdrawn | Many Locations, Vietnam | |
Withdrawn | Many Locations, India | |
Withdrawn | Many Locations, Germany |
Primary Outcome
- Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3date_rangeTime Frame:Up to 42 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.date_rangeTime Frame:Up to 42 monthsenhanced_encryptionYesSafety Issue:
- Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first.date_rangeTime Frame:Up to 42 monthsenhanced_encryptionYesSafety Issue:
- Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration.date_rangeTime Frame:Up to 42 monthsenhanced_encryptionYesSafety Issue:
- Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countriesdate_rangeTime Frame:Up to 42 monthsenhanced_encryptionNoSafety Issue:
- Healthcare resource utilizationHospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapiesdate_rangeTime Frame:Up to 42 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A